CAVEAT: An Open-Trial Feasibility Study

NCT06552832 | Recruiting

• 1 other identifier: CHUV-SUPEA-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-clinical trial to study the feasibility of a brief manualized psychotherapy for mothers interpersonal violence-related posttraumatic stress disorder (PTSD) and their very young children ages 1-3 years, entitled: Clinician-Assisted Videofeedback Exposure Approach Therapy (CAVEAT). This project, to be conducted with referred mothers and children to an academic medical center ambulatory care setting, intends to pilot along with the manualized intervention, pre- and post-intervention measures for up to 10 dyads over 2 years.

Conditions

Parent-Child Relations; PTSD; Dissociation

Keywords

Brief Psychotherapy; Videofeedback; Mentalization; Infant Mental Health; Parenting; Interpersonal Violence

Outcome Measures

Primary Outcomes (3)

• Parenting Stress Index- Short Form

  Self-report questionnaire

  Pre- and Post-Intervention within 6 weeks after last session

• Maternal Attributions Rating Scale

  Clinician-rated measure

  Pre- and Post-Intervention within 6 weeks after last session

• Brief Infant-Toddler Social Emotional Assessment

  Maternal-report questionnaire

  Pre- and Post-Intervention within 6 weeks after last session

Secondary Outcomes (1)

• Intervention Satisfaction Questionnaire

  Post-Intervention within 6 weeks after last session

Study Arms (1)

CAVEAT

EXPERIMENTAL

Clinician-Assisted Videofeedback Exposure

Other: CAVEAT

Interventions

CAVEAT OTHER

Brief manualized parent-child psychotherapy

CAVEAT

Eligibility Criteria

• Age: 12 Months - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• French-speaking, biological child living with mother

You may not qualify if:

• Physical and/or mental handicap that can interfere with participation in play and measures, active psychotic illness or substance abuse

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• Sandra Rusconi Serpa: collaborator

Study Sites (1)

Lausanne University Hospital, Child & Adolescent Psychiatry Service

Lausanne, Canton of Vaud, 1004, Switzerland

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Dissociative Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Daniel S Schechter, MD

CONTACT

+41213148558; daniel.schechter@chuv.ch

Ryan J Murray, PhD

CONTACT

+41213147485; ryan.murray@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Senior Consultant in Child & Adolescent Psychiatry

Model Details: Open Trial with Pre- and Post-Measures (Treatment as Usual as parallel contrast without randomization)

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: August 14, 2024
• Study Start: July 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CH (1)